Genentech’s Avastin gets review panel
Executive Summary
FDA's Oncologic Drugs Advisory Committee will review Avastin (bevacizumab) in combination with paclitaxel chemotherapy for patients who have not received chemotherapy for locally recurrent or metastatic breast cancer, Genentech announces Sept. 13. ODAC is scheduled to meet Dec. 4-5. Genentech resubmitted the sBLA in August, setting up a February 23, 2008 action date (1"The Pink Sheet" Aug. 27, 2007, In Brief). The resubmission followed a "complete response" letter issued by the agency in September 2006 that requested an independent review of patient scans for progression-free survival...
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Avastin resubmission
Genentech appears on target for a February user fee date on its resubmitted sBLA for Avastin (bevacizumab) as a first-line treatment for metastatic breast cancer in combination with paclitaxel. The firm announced the resubmission Aug. 24 and expects a six-month review. FDA requested an independent review of patient scans for progression-free survival in a "complete response" letter it sent to the firm Sept. 8 (1"The Pink Sheet" Oct. 2, 2006, p. 21). Genentech said the independent review results were consistent with its earlier positive findings...
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